Nicaragua Opens Public Consultation on Medical Device Registration Requirements

Date of update: June 2026

Nicaragua‘s Agencia Nacional de Regulación Sanitaria (ANRS) opened a public consultation on the First Addendum to NTON 24001:2023, Health Technology: Medical Devices , Requirements for Sanitary Registration.

The consultation invited observations and comments on the proposed addendum, with a submission deadline of July 1, 2026.

The Proposed Addendum

The public consultation concerned the First Addendum to NTON 24001:2023, the technical standard addressing sanitary registration requirements for medical devices.

The announcement included the draft regulation for review, along with a form for submitting observations or comments.

Public Consultation and Submission Process

Comments and observations were accepted until July 1, 2026.

Participants were instructed to submit their feedback using the provided template and send it to imartinez@cnnc.gob.ni.

The announcement made the draft text and corresponding form available as part of the consultation process.

Regulatory Status

The announcement concerned a public consultation on the proposed addendum to NTON 24001:2023.

It provided the consultation deadline and submission instructions but did not specify a final approval date or an effective date for the proposed changes.